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This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. This approval is based on two clinical studies: TROPION-Lung05 and TROPION-Lung01, where efficacy was assessed in 114 patients with EGFR-mutated NSCLC. Fifty-three percent (53%) of patients had exon 19 deletions, 34% had exon 21 L858R mutations, 28% had T790M mutations, 2.6% had exon 20 insertion mutations, and 14% had other EGFR mutations.", "contributions": [ { "id": "ctrb:vanallenlab:2025-09-02:1", "type": "Contribution", "description": "The US FDA approved datopotamab deruxtecan for the treatment of adult patients with locally advanced or metastatic EGFR mutated non-small cell lung cancer who have received prior EGFR-directed therapy and platinum-based chemotherapy.", "date": "2025-09-02", "contributor": { "id": "agent:user:vanallenlab", "type": "Agent", "agentType": "contributor", "name": "Van Allen lab", "description": "Van Allen lab, Dana-Farber Cancer Institute" } }, { "id": "ctrb:fda:2025-06-23:0", "type": "Contribution", "description": "Indication received accelerated approval.", "date": "2025-06-23", "contributor": { "id": "agent:org:fda", "type": "Agent", "agentType": "organization", "name": "Food and Drug Administration", "description": "Regulatory agency that approves drugs for use in the United States." } } ], "reportedIn": [ { "id": "doc:fda:datroway", "type": "Document", "documentType": "Regulatory approval", "name": "Datroway (datopotamab deruxtecan-dlnk) [package insert]. 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